Articles Posted in Products Liability

Earlier this month, the Eighth Circuit Court of Appeals decided a case in favor of a woman whose husband was killed when a gun in his friend’s possession accidentally discharged. The court’s opinion in the case, O’Neal v. Remington Arms Company, held that the plaintiff submitted enough proof of negligence on the part of the gun manufacturer for the case to proceed towards trial.

The Facts of the Case

According to the court’s written opinion, Remington used a “Walker trigger” in weapons dating back to 1971. At some point between then and now, Remington was made aware that there was a potential defect in the trigger mechanism, and that the gun may fire when the safety is turned off, even though the trigger was not pulled. Remington, knowing this, did not recall the roughly 20,000 rifles affected by the potential hazard and allowed them to remain for sale and in the market.

In 2008, the plaintiff’s husband went hunting with some friends. He loaned his Remington rifle to one of his friends. At some point on the hunting trip, the friend pulled the rifle out when he spotted a deer, and the gun accidentally discharged, killing O’Neal. O’Neal’s wife filed suit against Remington for the negligent design of the trigger mechanism.

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Although the tragic events happened two years ago, lawsuits are still being filed for damages resulting from the Sugarland concert stage collapse at the 2011 Indiana State Fair. The outdoor show stage area was suffering extensive wind gusts at the time. The temporary roof structure of the stage collapsed and landed among the crowds. Seven people were killed in the event and nearly 60 were injured.The Fireman’s Fund Insurance Company is the latest to file suit, only moments before the statute of limitations expired on its claims. The company was responsible for insuring the musical instruments and equipment of the bands, which all suffered extensive damage during the collapse. The lawsuit alleges negligence and products liability. The terms of the lawsuit allege that the stage rigging was not properly erected. The suit is naming a group of parties who were responsible for varying stages of constructing, erecting, and maintaining the stage.

Sugarland, a country music duo, had not yet appeared on stage but were finishing their warm-ups when the collapse occurred. Two months after the accident the band played a free concert in Indiana to support those affected by accident. A court date of February 2014 has been scheduled to determine whether the two members of Sugarland, Jennifer Nettles and Kristian Bush, may have any share of liability for the incidences of that evening.
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Conflicts between state and federal laws governing prescription drugs led the Alabama Supreme Court to rule that a plaintiff allegedly injured by a generic drug may sue the manufacturer of its brand-name equivalent. In re Wyeth, Inc., et al v. Weeks, No. 1101397, slip op. (Ala., Jan. 11, 2013). Because the plaintiff’s claim alleged deficiencies in the warning label, and not the manufacturing process, the court found that it was “not fundamentally unfair,” slip op. at 52, to hold the defendant liable. The defendant was responsible for drafting the warnings, and the generic manufacturer’s responsibility was to reprint those warnings. The ruling could affect state-level pharmaceutical cases around the country.

The plaintiffs, a married couple, filed suit against five pharmaceutical companies, alleging that the husband suffered injuries from taking the drug metoclopramide, marketed under the brand name Reglan. The drug is used in short-term treatment of various stomach and intestinal conditions, including persistent heartburn. It has been associated with a risk of tardive dyskinesia (TD), a neurological disorder that affects body movements. The plaintiffs allege that the defendants breached a duty to warn Mr. Weeks’ physician of the risk of TD and other side effects. They concede that he never took brand-name Reglan manufactured by Wyeth, but rather generic variants manufactured by other companies. The plaintiffs claim instead that Wyeth and other brand-name manufacturers “falsely and deceptively misrepresented or knowingly suppressed facts about” the drug. Id. at 6.
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An appellate court ruled in favor of a pharmaceutical company in an appeal of a summary judgment order and a jury verdict in a multi-district products liability lawsuit. Secrest v. Merck, Sharp & Dohme Corp., part of In re: Fosamax Products Liability Litigation, No. 11-4358-cv (2nd Cir., Jan. 30, 2013). The Second Circuit affirmed a district court’s order granting summary judgment for the defendant (PDF file) on a failure to warn claim, and in a separate ruling issued the same day, it affirmed a jury verdict in favor of the defendant on a design defect claim. Several days after the court’s ruling, a federal jury ruled in favor of a different plaintiff on a failure to warn claim. The two cases illustrate the difficulty of proving causation and damages in large pharmaceutical cases.

Fosamax, the drug at the center of the litigation, was used to treat osteoporosis in women going through menopause. An alleged link between the drug and osteonecrosis of the jaw (ONJ), a condition in which the jawbone begins to die, led to a wave of products liability lawsuits around the country. Some plaintiffs also allege that the drug contributed to femur fractures and other bone injuries. The Judicial Panel on Multidistrict Litigation consolidated most of the pending federal lawsuits in the U.S. District Court for the Southern District of New York.

Plaintiff Linda Secrest filed suit against Merck, Fosamax’s manufacturer, in Florida in 2006, asserting causes of action for design defects and failure to warn of the drug’s risks. She claimed that she took Fosamax from June 1998 until March 2003, and then began taking it again under a different doctor in December 2003 through April 2005. She developed ONJ around March 2004. The trial court granted the defendant’s motion for summary judgment on her failure to warn claim, and a jury entered a verdict in Merck’s favor in October 2011 on the design defect claim.
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A pharmaceutical sales representative’s conviction for conspiracy to introduce a misbranded drug into interstate commerce violated his rights to free speech under the First Amendment, according to the Second Circuit’s ruling in United States v. Caronia, No. 09-5006-cr, slip op. (2nd Cir., Dec. 3, 2012). The court held that the representative’s speech, consisting of the off-label marketing of a drug, was the principal basis for the government’s criminal case, and that the regulations regarding such marketing were overbroad for the goal of maintaining safe drug labeling. The decision adds an interesting and important dimension of constitutional law to the issue of drug safety and medication errors.

The drug at the center of the case is Xyrem, a central nervous system depressant used for narcolepsy. It has a reputation as a “date rape drug” because its active ingredient, gamma hydroxybutrate, can cause abrupt loss of consciousness in sufficiently large doses. It is therefore subject to strict regulations as to its approved uses. The U.S. Food and Drug Administration (FDA) has only approved it for two uses, both related to narcolepsy: excessive daytime sleepiness and cataplexy, a sort of temporary paralysis associated with the condition. Xyrem was developed by Orphan Medical, which is now part of Jazz Pharmaceutical.

Before a pharmaceutical company may introduce a new drug into the marketplace, it must obtain approval from the FDA for specified uses, and the law states that its marketing may only reference these approved uses. The federal Food, Drug, and Cosmetic Act (FDCA) prohibits drug companies and their representatives from introducing “misbranded” drugs into the marketplace, which may include information that is “false or misleading,” or that suggests uses that are “dangerous to health.” Caronia, slip op. at 7, n. 4. The law does not, however, prohibit “off-label” promotion of drugs by physicians when speaking directly to patients. For pharmaceutical companies and their sales representatives, the FDCA imposes criminal penalties for misbranding drugs, but it does not specifically criminalize “off-label” promotion of drugs.
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A nationwide outbreak of fungal meningitis, traced to medications from a Massachusetts compounding pharmacy, has prompted lawmakers and others to propose strengthening oversight and regulation of compounding pharmacies around the country. These pharmacies currently have no consistent system of federal oversight, although state governments have a wide range of regulations intended to promote drug quality and patient safety. Indiana’s Board of Pharmacy responded to the meningitis outbreak with reassurances about its oversight.

Two bills introduced towards the end of the last session of the 112th Congress sought to give the U.S. Food and Drug Administration (FDA) additional regulatory authority over certain compounding pharmacies, but neither bill made it out of committee. H.R. 6584, The Verifying Authority and Legality In Drug (VALID) Compounding Act, would have subjected compounding pharmacies that act as drug manufacturers to the same FDA regulations as drug manufacturing companies. It also would have required pharmacies to label compounded drugs to indicate that the FDA had neither inspected nor approved the drug, required reporting of adverse reactions to compounded drugs, and created a public “Do Not Compound” list.

H.R. 6638, the Supporting Access to Formulated and Effective (SAFE) Compounded Drugs Act, would have mandated FDA registration for all compounding pharmacies, labeling of all compounded drugs, and FDA production standards and training programs for state health officials. It also would have required disclosure to patients that they are receiving a compounded drug, and improvements to communication between federal and state health regulators. Both bills were referred to the House Subcommittee on Health, where they died at the end of the 112th Congress.
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A lawsuit filed by an anonymous company sought to remove allegedly false or misleading information about the company’s product from an online product safety database maintained by a federal agency. The plaintiff in Company Doe v. Tenenbaum, No. 8:11-cv-02959, slip op. (D. Md., Oct. 22, 2012), alleged that a report submitted to the website described injuries or damages that were not caused by its product. The court reviewed Congress’ intent in mandating the creation of the website and ruled that reports in the database need to show a direct connection between the product and the injury. It granted the plaintiff’s motion for summary judgment and ordered that the report in question be sealed. The court’s opinion offers important insight for consumers into how federal courts may view the fundamental standards of proof in products liability claims.

Congress mandated the creation of an online database of product safety information in the Consumer Product Safety Information Act of 2008 (CPSIA). 15 U.S.C. § 2055a. The Consumer Product Safety Commission (CPSC) launched SaferProducts.gov in accordance with the law’s requirements. The database contains product safety information obtained from medical professionals, government entities, safety organizations, child care organizations, and reports submitted by consumers. Id. at § 2055a(b)(1). Consumers submitting reports must provide their own names and contact information, along with descriptions of the product and the damage, the identity of the manufacturer or labeler, and a verification stating that the information is true and correct. Id. at § 2055a(b)(2)(B). The law requires the CPSC to provide any manufacturer or labeler identified in consumer-submitted reports with copies of those reports, with an opportunity to comment on or dispute the consumer’s charges. Id. at § 2055a(c).
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“Energy drinks,” a general category of drinks with high levels of stimulants like caffeine, taurine, and guarana, have been the subject of much scrutiny in recent years, as their excessive consumption has allegedly led to multiple injuries and deaths. Four Loko, an energy drink that also contains alcohol, has been especially controversial, earning the nickname “Blackout in a Can” among many college students. A series of lawsuits has alleged that the stimulants in the beverage mask the effects of the alcohol, leading to over-consumption, risky behavior, and in some cases, injury or death.

Two insurance companies, including one based in Indiana, have filed a federal lawsuit requesting a declaration that they are not obligated to defend or indemnify Four Loko’s manufacturer, Phusion Projects, in these lawsuits. The companies have reportedly already obtained a similar declaratory judgment, meaning that it may prove difficult for future claimants to recover damages from the beverage maker.

The mixture of caffeine and alcohol, according to doctors quoted by Fort Wayne’s WANE News, can pose serious health risks by concealing the depressive effect of the alcohol content and making the individual more likely to continue drinking. The person might not feel drunk because of the caffeine content, so the person is allegedly also more likely to engage in risky behaviors like driving.
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A welder filed a products liability lawsuit, claiming that defects in the shirt he was wearing caused it to catch fire while he was operating a plasma torch. The suit, Hathaway v. Cintas Corporate Services, Inc., also asserted causes of action for breach of warranty and negligence. The District Court for the Northern District of Indiana granted summary judgment for the defendant on the breach of warranty and products liability claims, but allowed the negligence claim to proceed.

Plaintiff Rex Hathaway worked for Quik Cut, Inc. as a welder and plasma torch operator. His employer used uniforms provided by the defendant, Cintas Corporate Services. The rental agreement between Quik Cut and Cintas provided that Cintas would furnish work clothes and provide laundry and repair services. Hathaway was operating a plasma torch, a machine used to cut various types of metal, on February 12, 2009. Sparks from the plasma torch allegedly caused Hathaway’s shirt, a 100% cotton shirt provided by Cintas, to catch fire, and he suffered severe burns over much of his body.

Hathaway filed suit against Cintas, asserting causes of action for negligence, breach of warranty, and products liability. His wife also brought a cause of action for loss of consortium. Hathaway alleged that the shirt had both a manufacturing defect and a design defect, and he claimed that Cintas was liable for failure to warn of the risk of injury.

Cintas moved for summary judgment on the negligence, breach of warranty, and products liability claims. The court first ruled that the plaintiff’s breach of warranty claim was subsumed by his products liability claims. The court held that because the plaintiff did not claim economic damage for the loss of the shirt, the breach of warranty claims were based in tort, and were therefore part of the products liability claim under the Indiana Products Liability Act (IPLA).
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An Illinois appellate court overturned a $30 million verdict in favor of a chemical-flavoring plant worker who claimed that a chemical used in popcorn butter flavoring caused him permanent lung damage. The verdict in Solis v. BASF Corporation was reportedly the largest in a series of popcorn flavoring lawsuits. The appellate court reviewed the question of whether Illinois’ statute of limitations barred the plaintiff’s claim, and ruled that the trial court erred by rendering a directed verdict for the plaintiff on that issue.

The plaintiff, Gerardo Solis, began a nearly two-decade career in the flavoring industry in 1987. His job duties, according to the court’s opinion, often involved working with or near butter flavorings containing the chemical diacetyl. Solis worked at Flavorchem from 1998 to 2006. He spent two years as a compounder, which involves mixing different ingredients to create a final flavor product. He was then promoted to supervisor, but continued primarily working in the area of the plant that produced powder flavorings. He claimed that he noticed an increase in the plant’s use of diacetyl, particularly in butter flavorings for popcorn, beginning in 2000, and that he experienced significant exposure to the chemical from 2000 to 2004.

Diacetyl provides the buttery flavor and aroma in popcorn and other food products. It has been linked to respiratory problems in workers with prolonged exposure, including bronchiolitis obliterans, an inflammation of the small airways in the lungs. This can cause a permanent loss of pulmonary function in some cases. A recent study also found a link between diacetyl and a brain protein believed to contribute to Alzheimer’s disease. Solis received a diagnosis of bronchiolitis obliterans in June 2006. He allegedly suffered permanent lung damage and was eventually told he needed a lung transplant.
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